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  • Regulatory NewsRegulatory News

    Industry, Advocacy Groups Seek Clarity on Proposed Changes to Informed Consent Rules

    Trade associations representing the medical device and clinical research industries, as well as the nonprofit public advocacy organization Public Citizen, are calling for the US Food and Drug Administration (FDA) to clarify provisions of its proposed rule for institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.   Background   Under current FDA regulations...
  • Regulatory NewsRegulatory News

    FDA Inspection Finds Minnesota Hospital Violated Informed Consent, IRB Rules

    In an inspection report obtained by Public Citizen, the US Food and Drug Administration (FDA) cites the Hennepin County Medical Center over its institutional review board’s (IRB) oversight of clinical trials that involved dosing emergency patients with ketamine and other sedatives without the patients’ consent.   The inspection, which ran from 7-24 August, came after the Star Tribune reported on clinical trials conducted by the hospital and just weeks after Public C...
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    FDA, HHS Finalize Guidance on Documenting IRB Activities

    The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on Monday finalized a 2015 draft guidance on how to document institutional review board (IRB) activities. The guidance, developed jointly by the two agencies, details how and what IRBs should document in the meeting minutes they are required to keep under 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2), which include: Attendance at the me...
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    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...
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    NIH Finalizes Single IRB Policy to Reduce Redundancies

    The National Institutes of Health (NIH) on Monday finalized a policy that will require NIH-funded clinical studies to be overseen by a single institutional review board (sIRB), beginning in May of next year. NIH made the announcement in a notice published to the Federal Register , saying its goal is to "enhance and streamline the IRB review process" for multi-site clinical trials. Overall, NIH says feedback on the policy was supportive, though some commenters felt the ...
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    FDA Warns Monmouth Medical Center IRB Over Conflict of Interest Issues

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Monmouth Medical Center, a New Jersey hospital, after an inspection of its institutional review board (IRB) found it failed to follow regulations meant to protect clinical trial participants, including for pediatric studies. Specifically, the IRB failed to adequately document whether clinical investigations involving pediatric subjects were in compliance with FDA regulations, or document wh...
  • Regulatory NewsRegulatory News

    FDA Unveils Draft Guidance on How to Document IRB Activities

    The US Food and Drug Administration (FDA) has joined forces with the Office for Human Research Protections (OHRP) to prepare draft guidance on how to record the activities of institutional review boards (IRBs). The guidance offers advice for institutions, or in some cases the IRBs themselves, that have to prepare and document IRB activities via minutes, which should include summaries of what occurred during a convened meeting and the IRB’s findings and determinations.  ...
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    NIH Calls for Changes to Federal Research Oversight Policies

    The National Institutes of Health (NIH) is trying to simplify the oversight of complex, multi-center clinical trials through a new policy promoting the use of a single institutional review board in trials it oversees. Institutional review boards (IRB), sometimes known as ethics committees in foreign countries, are meant to ensure that clinical trial participants are treated safely and fairly in accordance with local, national and international regulations. Traditionally...
  • Regulatory NewsRegulatory News

    FDA Revises Policies on Obtaining Informed Consent in Clinical Trials

    A new draft guidance document issued by the US Food and Drug Administration (FDA) is meant to eventually replace a 16-year-old guide outlining the regulator's views on informed consent. Informed Consent: The Basics As FDA explains in the draft guidance, Informed Consent Information Sheet , when most people think about the process of obtaining consent, they think of it as obtaining written consent from the subject to participate in a medical study. But FDA says this...
  • Regulatory NewsRegulatory News

    FDA Finalizes IRB Transfer Guidance With Minimal Changes

    • 22 May 2014
    The US Food and Drug Administration (FDA) has announced the release of a final document intended to instruct sponsors, clinical investigators and institutional review boards (IRB) about how to transfer the oversight of clinical trials to a new IRB. The guidance, Considerations When Transferring Clinical Investigation Oversight to Another Institutional Review Board , was first released in draft form in June 2012 by FDA and the US Department of Health and Human Servic...
  • Final FDA Guidance on IRBs Illustrates Common Problems Faced in Trial Setup Phase

    The US Food and Drug Administration (FDA) has announced the publication of a new guidance document intended to guide institutional review boards (IRBs), clinical investigators and sponsors of clinical trials on whether clinical sites are compliant with regulations and whether an investigational application must be submitted to FDA. Background Clinical research is at the heart of FDA's regulatory oversight capacity. Good review decisions rely on good clinical data-r...
  • Stem Cell Processor, IRB Targets of Related Warning Letters from FDA

    The US Food and Drug Administration (FDA) is continuing to enforce a controversial policy involving the regulation of stem cell therapies, which the agency defends as enforcing established authority but critics have derided as the regulation of the practice of medicine. A 24 September warning letter to Texas-based CellTex Therapeutics Corporation references the firm's use of adipose tissue (lipoaspirate) recovered from donors, which is then isolated and cultured into adi...